The ABPI is at the heart of a health sector-wide effort to establish consensus on key Brexit issues including medicines regulation, UK and EU trading relationships, access to talent, and the future of UK science.

The relationship between the pharmaceutical industry and healthcare professionals (HCPs) and healthcare organisations (HCOs) plays a vital role in the development and delivery of life-enhancing and life-saving medicines.

As a membership organisation we work with our member companies, and the expertise of the specialists they employ, to develop and present our points of view to UK and European governments, the public and to other stakeholders.

Pragmatism and hard work required – what the ‘no deal’ notices mean for pharma

Elliot Dunster, Head of External Affairs at the ABPI, takes a closer look at the 'no deal' guidance published by Government.

Yesterday the Government published the first tranche of their ‘no deal’ technical notices to help prepare for the possibility of the UK leaving the EU without a deal.

Alongside the publication of the technical notices, the Health Secretary, Matt Hancock MP, also issued letters to pharmaceutical companies, medical devices companies and the NHS frontline to give guidance about how they should prepare for ‘no deal’.

Since last year, the ABPI has advised pharmaceutical companies that as they prepare for all possible outcomes from the negotiations, they should ensure they are ready for a ‘no deal’. This guidance will help companies make these preparations and the ABPI has been looking closely at how this guidance will impact on companies.

And there’s a lot in there to unpack with notices on Horizon 2020; batch testing of medicines; quality and safety of organs, tissues and cells; medicines, medical devices and clinical trials regulation; submitting regulatory information on medicinal products; trade; VAT for business; and tariffs.

Here are some initial thoughts on some of the most important aspects of the announcement.

A practical, pragmatic approach to the regulation of medicines

Companies will be warmly welcome the pragmatic approach set out in the technical notice on ‘medicines, medical devices and clinical trial regulation’. The notice states that, ‘In order to ensure continuity of supply in medicines, however, the UK will continue to accept batch testing of human medicines carried out in countries named on a list set out by the MHRA.’ This list will include EU and EEA countries. This announcement was a central part of Dominic Raab’s speech.

As the notices make clear, if there’s ‘no deal’, the UK would no longer be part of the EMA network and the sharing of common systems and exchanges of data would end. That’s why announcing that the UK would recognise EU batch testing and release of medicines is critical to ensure they are available to UK patients from day 1 of Brexit.

Consultations to come

A key feature of the technical notice on how companies would submit regulatory information on medical products was that there will be an consultation from the MHRA in the autumn. This consultation will look at the ‘new systems’ that are being developed for March 2019, including a ‘national portal for companies to submit regulatory information to’, alongside a range of other issues. This is likely to inform the necessary statutory instruments to the EU Withdrawal Bill.

The ABPI will be working with members and responding to this consultation in full.

It won’t be easy

The letter from the Health Secretary to pharmaceutical companies didn’t form one of the ‘technical notice’, but was published separately alongside letters to medical device companies and the NHS. The key requests to pharmaceutical companies were to have a minimum of six weeks additional supply of medicines which arrive in the UK from or via the EU; and to make arrangements to ‘air freight’ products with short shelf lives.

ABPI members have been planning since the day of the referendum result. And some have been public about the work they have done to increase their stocks of specific medicines, and many already have significant stocks of medicines.

But this won’t be easy. The letter talks about Government ‘support’, and the ABPI engaging with Government closely about what the support should look like.

… and we still need a deal

The October EU Council meeting takes on ever more important significance. Dominic Raab and Michel Barnier have agreed that the negotiations will progress on a weekly basis in the run up to that meeting.

What is clear is that the UK Government and the EU Commission agree there needs to be a deal. We agree. Mike Thompson, ABPI’s CEO was able to say this directly to Dominic Raab at the press conference after his speech. We need the full focus of Government on getting the right deal.

Getting a deal, which includes cooperation on medicines, is in the best interests for patients not just in the UK but in the EU as well.

Getting a deal, which includes cooperation on medicines, is in the best interests for patients not just in the UK but in the EU as well.

Elliot Dunster, Head of External Affairs, ABPI

ABPI

The Association of the British Pharmaceutical Industry is a company limited by guarantee registered in England and Wales(registered number 09826787) and its registered office is at 7th Floor Southside,105 Victoria Street, London, SW1E 6QT.Telephone +44 (0) 207 9303477

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The Prescription Medicines Code of Practice Authority (PMCPA) was established by The Association of the British Pharmaceutical Industry to operate the ABPI Code of Practice for the Pharmaceutical Industry independently of the ABPI. The PMCPA is a division of ABPI which is a company registered in England and Wales (registered number 09826787) with its registered office at 7th Floor, Southside, 105 Victoria Street, London SW1E 6QT.

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